Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 12:00 AM
NCT ID:
NCT05553158
Eligibility Criteria:
Inclusion Criteria
* Females aged 18 - 65 years
* Having one or more symptoms of PCS
* Symptoms: Aching / dragging in pelvis on sitting and/or standing, aching/tender /painful vulval varicose veins, irritable bowel, irritable bladder, deep dyspareunia, low back pain, hip pain with no or very mild changes on hip x-ray.
* Able to understand study and give written consent.
* Able to have trans-vaginal ultrasound scan and attend for follow-up.
Exclusion Criteria
* Under 18 years of age or over 65 years of age
* Currently pregnant, actively trying to get pregnant, planning pregnancy within next 12 months or within 3 months of child-birth
* Current symptoms due to diagnosed gynaecological conditions
* Current or previous malignancy
* Unable or refuse to consent to trans-vaginal ultrasound scan or any other aspect of the study
* Previous abdominal or pelvic surgery (excluding diagnostic laparoscopy)
* Previous embolization of pelvic veins
* Previous deep vein thrombosis, pelvic embolisation, venous intervention in abdomen or pelvis (stent, filter)
* Any vascular malformation of the pelvis or the legs apart from that diagnosed as venous reflux disease.
* Any medical condition likely to cause death or serious ill health within the next five years.
* Any deep venous obstruction or reflux on duplex ultrasound.
* Unable to wear compression garments on lower abdomen / pelvis
* Unable to wear leg compression garments
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05553158
Study Brief:
Protocol Section:
NCT05553158